Hitachi Scenaria Whole-body X-ray CT System — Class II medical device recall Z-0271-2020
Terminated recall by Hitachi Medical Systems America Inc, reported 2019-11-13, distributed in CA, FL, GA, IA, IN, MD, MT, NC…. There is a possibility that the cables to the controller unit may not be affixed properly, creating the potent
| Recall number | Z-0271-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hitachi Medical Systems America Inc, Twinsburg, OH, United States |
| Recall initiated | 2019-10-16 |
| Classified | 2019-11-01 |
| Reported by FDA | 2019-11-13 |
| Terminated | 2020-04-30 |
| Distributed | CA, FL, GA, IA, IN, MD, MT, NC, NY, OH, OK, PR, SD, TN, TX, WY |
| Countries outside the US | BR, MX |
| Quantity | 39 |
| Reason classes | device malfunction |
Product
Hitachi Scenaria Whole-body X-ray CT System
Reason for recall
There is a possibility that the cables to the controller unit may not be affixed properly, creating the potential for a cable to detach during scanning and eject from the system.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0271-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.